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Transcranial Direct Current Stimulation for Migraine Attack

Primary Purpose

Acute Migraine

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Migraine

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 17-70 years

  • Migraine

    • With or without aura
    • The first attack of migraine was earlier than 50 years of age
    • One to 8 moderate to severe migraine attacks per month in the 2 months preceding the screening
  • Willing and able to give written informed consent
  • Able to read, comprehend and complete the diary form

Exclusion Criteria:

  • Not able to distinguish between migraine and non-migraine headache
  • Combined headache, including the tension type headache and medication overuse headache
  • Pregnant, actively trying to become pregnant or breast-feeding women
  • Uncontrolled and significant medical illness
  • Vertebrobasilar or hemiplegic migraine according to the International Headache Society diagnostic criteria
  • Having intracranial metal implants or a cardiac pacemaker
  • A history of epilepsy or other organic brain disorders
  • A history of psychological diseases
  • Having changed medications for migraine within 1 month before giving us informed consent
  • Drug abuser or alcoholics

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

migraine

Arm Description

Outcomes

Primary Outcome Measures

Number of participants who experienced pain relief of one level or more

Secondary Outcome Measures

Full Information

First Posted
May 18, 2011
Last Updated
October 23, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01358279
Brief Title
Transcranial Direct Current Stimulation for Migraine Attack
Official Title
Manho Kim, MD, PhD Professor, Neurology Seoul National University Hospital,
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

Brief Summary
This study is conducted to investigate the therapeutic efficacy and safety of transcranial direct current stimulation (tDCS) over the primary motor cortex of patients with acute migraine attack.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
migraine
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
A constant current of 2 mA intensity applied for 20 min over C3 or C4
Primary Outcome Measure Information:
Title
Number of participants who experienced pain relief of one level or more
Time Frame
at 2h post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 17-70 years Migraine With or without aura The first attack of migraine was earlier than 50 years of age One to 8 moderate to severe migraine attacks per month in the 2 months preceding the screening Willing and able to give written informed consent Able to read, comprehend and complete the diary form Exclusion Criteria: Not able to distinguish between migraine and non-migraine headache Combined headache, including the tension type headache and medication overuse headache Pregnant, actively trying to become pregnant or breast-feeding women Uncontrolled and significant medical illness Vertebrobasilar or hemiplegic migraine according to the International Headache Society diagnostic criteria Having intracranial metal implants or a cardiac pacemaker A history of epilepsy or other organic brain disorders A history of psychological diseases Having changed medications for migraine within 1 month before giving us informed consent Drug abuser or alcoholics
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Transcranial Direct Current Stimulation for Migraine Attack

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